Biomedical Devices (eBook)

Tugrul Özel is the Director of Manufacturing & Automation Research Laboratory and a Professor in the Department of Industrial & Systems Engineering at Rutgers University in the USA. Paulo Bártolo is Chair of Advanced Manufacturing Processes, Director of the Manchester Biomanufacturing Centre, and a Professor at the School of Mechanical, Aerospace and Civil Engineering, University of Manchester in the UK. Elisabetta Ceretti is a Professor in the Department of Mechanical and Industrial Engineering at the University of Brescia in Italy. Joaquim De Ciurana Gay is a Professor in the Department of Mechanical and Industrial Construction at the University of Girona in Spain. Ciro Angel Rodriguez is Director of the Center of Innovation and Strategic Products Design and a Professor at Tecnológico de Monterrey in Mexico. Jorge Vicente Lopes Da Silva is Director of the Center for Information Technology Renato Archer in Brasil.

List of Contributors

Foreword

Chapter 1: Introduction

1.1 Introduction

1.2 Need for Medical Devices

1.3 Technology Contribution to Medical Devices

1.4 Challenges in Medical Device Industry

Chapter 2: Design issues in medical devices

2.1 Biomedical product life cycle

2.2 Medical device development process

2.3 Medical devices design process

2.4 Case study

2.4.1 Scapholunate interosseous ligament

2.4.2 Tracheal stent

2.5 Conclusions

References

Chapter 3: Forming Applications

3.1 Typical Process Parameters

3.1.1 Temperature

3.1.2 Flow stress

3.1.3 Strain

3.1.4 Strain rate

3.1.5 Tribology and micro-tribology

3.2 Manufacturing process chain

3.2.1 Manufacture of alloys and raw materials

3.2.2 Forming

3.2.3 Machining and finishing

3.2.4 Coating

3.2.5 Packaging and sterilization

3.3 Implantable devices

3.4 Bone implants

3.4.1 External fracture fixation

3.4.2 Artificial joint replacement

3.4.3 Spinal implants

3.4.4 Craniomandibular implants

3.4.5 Dental implants

3.5 Other biomedical applications

References

Chapter 4: Laser Processing Applications

4.1 Introduction

4.2 Micro-scale medical devices applications

4.3 Processing methods for medical device fabrication

4.4 Biomaterials used in medical devices

4.5 Micro-joining of similar and dissimilar materials

4.6 Laser micromachining for microfluidics

4.7 Laser micromachining for metallic coronary stents

References

Chapter 5: Machining Applications

5.1 Introduction

5.2 Machinability of biocompatible metal alloys

5.3 Surfaces engineering of metal implants

5.4 Wear and failure of metal implants

5.5 Micro milling-based fabrication of metallic micro channels for medical devices

5.6 Machining-based fabrication of polymeric micro needle devices

References

Chapter 6: Inkjet and Extrusion Based Technologies

6.1 Introduction

6.2 Inkjet Technology

6.2.1 Inkjet 3D Printing Technology

6.2.2 Materials in Inkjet Based Technologies

6.2.3 Inkjet Printing Methods

6.2.4 Inkjet Printing Systems: Processes and Machines

6.2.5 Medical Applications of Inkjet Technology

6.3 Material Extrusion Technology

6.3.1 Material Extrusion - General Principles

6.3.2 Extrusion based Technologies

6.3.3 Medical Applications of Extrusion-based systems

References

Chapter 7: Certification for medical devices

7.1 The medical devices approval, registration or certification

7.2 The pre-market key activity: the demonstration of the conformity to the safety and performance requirements

7.3 The post-market key activity: the surveillance

7.4 The role of the quality management systems

7.5 The verification and the auditing

7.6 The role of the Standards

7.7 Examples of approbation/certification roads in some world areas

7.7.1 European Union

7.7.2 United States of America

7.7.3 Japan

7.7.4 Australia

7.7.5 Brazil

7.7.6 Canada

7.8 In depth studies

7.8.1 Essentials of safety and performance principles (Source: IMDRF document GHTF/SG1/N68:2012)

7.8.2 Essentials of the risk management (Source: IMDRF document GHTF/SG3/N15R8)

7.8.3 Essentials of the not-clinical evaluation

7.8.4 Essentials of the clinical evaluation (Source: IMDRF documents GHTF/SG5/N1R8:2007-N2R28:2007-N3:2010)

7.9 References

7.10 List of Tables

Index